5 Essential Steps of the Probiotic Manufacturing Process
In 2018 the global probiotics market size was over $2 billion and is estimated to grow at a CAGR of 7.3% between 2019 and 2026. So, if you’re planning to enter the probiotics supplement market, the returns would be promising. But you need to ensure that you’re producing good quality supplements.
Let me also tell you that the manufacturing process is highly sensitive and requires competent equipment and knowledge to produce supplements that are well-received by the consumers. Although probiotics fall in the dietary supplements category, manufacturing them might differ from the usual. Let’s see how.
How are Probiotics Manufactured?
Step 1: Strain Selection
Strain selection is the first vital step in the probiotics manufacturing process. The strain selection solely depends on your goal for creating a specific probiotics supplement and your potential health claims. Whether you want to create a supplement to support digestion, boost the health of your immune system, support a healthy response to occasional stress, or more.
Each strain has specific features, and they support particular benefits. Some strains support healthy immunity, while others support lactose digestion. It's needless to say that for producing high-quality supplements, you need excellent-grade probiotics raw materials. The selected strains should survive within the gut to prove the efficacy.
The genus for each of the commonly used probiotics include -
Lactobacillus refers to a group of lactic acid producing friendly bacteria that make up many of the 400 normal probiotic species in the human body.[i] Lactobacilli provide many benefits, including the following:
- Inducing growth factors and increasing the bioavailability of minerals.
- Stabilizing the mucosal barrier and decreasing intestinal permeability.
- Supporting a desirable balance in various types of bacteria by producing lactic acid and hydrogen peroxide.
- Immunomodulating effects such as promoting healthy immune function.
- Promoting healthy levels of Candida albicans.
Bifidobacterium normally colonize in the human colon and, like Lactobacillus species, also produce lactic acid. These probiotics are important organisms in the intestine in helping to create a microbial barrier to undesirable bacteria. In fact, some species of Bifidobacteria (including B. infantis, B. breve and B. longum) bind to the intestinal mucosa and interfere with the attachment of undesirable bacteria.
The Bacillus genus are spore-forming probiotic bacteria. The spore provides a protective encasement that allows almost indefinite storage until it is ready to be consumed and can survive transit through the stomach intact. Research indicates that the spore-like protein coating on Bacillus species allows them to survive stomach acid, reach the small intestine, germinate, and multiply. In addition, research has also shown that Bacillus species can tolerate bile, allowing it to survive within the small intestine as well.
One species from this bacteria genus, Streptococcus thermophilus, is used in the dairy industry for the fermentation of yogurt and several varieties of cheese.
Step 2: Media Formulation
Besides an effective formula with the correct doses of raw materials, selecting naturally bile and acid-resistant strains is vital. You should also ensure that they are tested for intestinal survivability. The chosen strains then undergo fermentation and stabilization.
A bio-processing lab studies the probiotic strain to check what controllable parameters and nutrients can be optimized for growth. A contract manufacturer can help you conduct this study. Once the unique combination of nutrients and process parameters are established, a large scale production can be commenced.
Step 3: Fermentation
The raw material for making probiotics can be sourced from across the globe. Further, probiotics are specifically manufactured per order to maintain freshness and quality. Cultivation of bacteria can take up to 6 weeks. You cannot rush the cultivation period while the cultures are grown. Many times, specific strain ID numbers are specific to the supplier of the material. So, you are dependent on a particular supplier as others can't provide you with the identical strain IDs. Also, other raw materials might not be readily available in the required quantity with the contract manufacturer, which can further delay the turn-around-time.
During fermentation, all the nutrients and equipment are sterilized to eliminate any unwanted and accidental contamination. The strain is added to the media in a huge tank. The strain multiplies in the nutritious and warm ingredient bath until it reaches the desired count (CFU – Colony-forming Units). During this process, metabolites are also formed, which is the by-product of the bacteria's metabolism of the nutrients.
Probiotics are challenging to work with during the production process and require a high amount of overages to ensure that each strain meets the claim mentioned on the supplement label.
Step 4: Centrifugation
Once the cultures are ready, you can separate probiotic strains from the metabolites. The stability of probiotics is another critical aspect that needs close attention in the probiotics production process. Probiotic products begin to lose their stability/freshness the moment they're packaged. Various methods are used to maintain supplement stability and potency for long-term storage. These processes are vital and influence the probiotic strains' viability and application suitability.
- Refrigeration - The probiotic bacteria are subjected to extremely low temperatures.
- Avoiding hot/humid environments - This step keeps the bacteria free from humidity. The step involves a few drying methods.
- Freeze Drying - A more prolonged but gentler process.
- Spray Drying - A shorter process characterized by higher temperatures, but not too high for the bacteria to survive.
After these processes, the probiotic is then transformed into a dry powder.
Step 5: Blending and Bottling
The above powder contains a single strain. For multi-strain formula, other probiotic powders are blended to form an evenly distributed, balanced mixture. Besides probiotics, other essential ingredients can be mixed, including prebiotics, flavoring ingredients, binders to produce alternate dosage forms, ingredients that complement the probiotic's health focus, etc. This blend then gets ready to be presented into its final dosage forms like tablets, capsules, and powder.
Probiotics are highly sensitive to environmental conditions such as temperature, humidity, and light. These conditions differ from strain to strain and affect the expiration of the product. Hence, they should be carefully packaged and prepared for shipment. They should be protected from direct sunlight, high temperature, and moisture.
The entire manufacturing process should be accompanied by quality testing.
How Can You Contract Manufacture a High-Quality Probiotic Dietary Supplement?
The probiotic manufacturing process demands expertise, state-of-the-art equipment, temperature, and humidity control storage and processing facilities. With in-depth know-how about probiotic supplement manufacturing and cGMP certified facilities, NutraScience Labs can help you create an effective probiotic supplement.
We are probiotic supplement contract manufacturers and can help you with end-to-end probiotic supplement production, including innovative formulation, trending flavors, and eye-catching and FDA compliant labeling and packaging. Our cutting-edge facilities and equipment enable rapid production time. Call 855-492-7388 to speak to one of our representatives or send us your request to receive a free price quote.